Trial Review

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Comparison of intranasal versus intravenous hydromorphone given in the postoperative period. Single-dose to be administered via first route (randomised order) at first onset of pain postoperatively, then single-dose via second route to be administered for pain between 12 and 24 hours later. Fentanyl PCIA for breakthrough pain in between these 2 doses.

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Intervention code [1]2770

Treatment: Drugs

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Comparator / control treatment

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Control group

Active

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Outcomes

Primary outcome [1]5120

Clinical effectiveness of a single dose of 2mg hydromorphone administered intranasally, as measured by redution of pain intensity at rest, compared with the administration of 1mg hydromorphone intravenously.

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Timepoint [1]5120

Pain scores (visual analogue scale - VAS) will be collected immediately prior to (baseline) and at 5, 15, 30, 60, 120 and 180 minutes after each method of hydromorphone administration.

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Secondary outcome [1]10980

Nausea, sedation and pruritus scores (VAS).

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Timepoint [1]10980

Collected immediately prior to and 60 minutes after hydromorphone administration.

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Secondary outcome [2]10990

Presence of side effects including pain or burning in the nasal passages.

Nasal pathology.Allergy to shellfish (chitosan a natural constituent of mollusc seashell is added to the hydromorphone mixture to aid in prolonging mucosal absorption).Intolerance to opioids.Decision to use epidural analgesia postoperatively.

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Study design

Purpose of the study

Treatment

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Allocation to intervention

Randomised controlled trial

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Procedure for enrolling a subject and allocating the treatment (allocation concealment
procedures)

Opaque envelop used to conceal route of first administration until time of dose

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Methods used to generate the sequence in which subjects will be randomised (sequence
generation)

Hydromorphone is an opiate drug quite similar to morphine and is widely used to treat pain after surgery. A recent idea is to use a patient controlled technique which allows the patient to self-administer the drug as they need using a nasal spray. Previous studies show the absorption of hydromorphone through the nasal mucosa is rapid within a few minutes and that pain relief is very effective. The advantage of this route of delivery is that it avoids the use of intravenous drips. In this study we will be comparing the intravenous route of administration with what happens after a similar dose of hydromorphone is given intranasally. This will help to detemine the most appropriate way to prepare the nasal drug and the best dose to give with each spray. Postoperatively patients who are using patient controlled intravenous analgesia will be given a dose of hydromorphone for pain before they are allowed to start using their pump. All patients will get an intravenous and an intransal dose 12-24 hours apart. The order of which comes first will be randomly allocated. Blood wil be taken from a previously sited cannula at intervals before and after doses to measure levels. At all times good pain relief is guaranteed by use of the fentanyl PCIA.